Indications and uses
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep.
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep.
take only one dose per day (24 hours) see Overdose warning adults & children 12 years and over 2 gelcaps at bedtime if needed or as directed by a doctor
(in each gelcap)
Diphenhydramine HCl USP, 25 mg
Nighttime sleep-aid
■ for relief of occasional sleeplessness
■ reduces time to fall asleep if you have difficulty falling asleep.
■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin
■ with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
■ a breathing problem such as asthma, emphysema, or chronic bronchitis
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
■ heart disease
■ taking sedatives or tranquilizers or any other sleep-aid
■ avoid alcoholic beverages and other drugs that cause drowsiness
■ drowsiness will occur
■ be careful when driving a motor vehicle or operating machinery
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
ask a health professional before use.
Keep out of reach of children.
Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.
take only one dose per day (24 hours) see Overdose warning
adults & children 12 years and over
2 gelcaps at bedtime if needed or as directed by a doctor
■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.
■ avoid high humidity
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red # 28, D&C red # 33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6 gelatin, hydroxyl propyl cellulose, hypromellose, iron oxide red, iron oxide yellow, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68016-789-48 | 2024-01-30 | C162847 | 48780-1 | 1030e365-14ee-111a-e063-dadaa90a10e2 | Sleep-Aid Diphenhydramine HCl USP, 25 mg NIGHTTIME SLEEP AID |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-789-48 | Diphenhydramine Hydrochloride | 48 in 1 BOTTLE | TABLET | 48 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68016-789 | 68016-789-48 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ba16b4eb-30dd-a8df-e053-2995a90af7f6 | 6bca78f3-6836-9a71-e053-2a91aa0ac3d6 | 2021-01-29 | Warnings | ba16b4eb-30dd-a8df-e053-2995a90af7f6 6bca78f3-6836-9a71-e053-2a91aa0ac3d6 |
Adverse event summaries are temporarily unavailable. Other product information remains available.